MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926012250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous mid circumflex artery.A 2.50 x 12 synergy ii drug-eluting stent was advanced for treatment.Upon insertion, the physician noted that they had slightly kinked the catheter shaft and attempted to straighten the shaft.The device was inserted and as it entered into the target vessel, the hypotube of the catheter fractured separating itself from the proximal portion of the catheter.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was excellent.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter (od) was measured and is within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a hypotube break 495 mm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted along the entire length of the catheter.This type of damages is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the shaft polymer extrusion found an inner/outer shaft polymer extrusion kink 44 mm distal to the port bond.A midshaft kink was also noted 110 mm proximal to the port bond.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The most probable root cause has been determined to be use/user error as the direction for use states: "at any time during use of the monorail stent delivery system, if the proximal shaft (hypotube) has been bent or kinked, do not continue to use the catheter¿.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the moderately tortuous mid circumflex artery.A 2.50 x 12 synergy ii drug-eluting stent was advanced for treatment.Upon insertion, the physician noted that they had slightly kinked the catheter shaft and attempted to straighten the shaft.The device was inserted and as it entered into the target vessel, the hypotube of the catheter fractured separating itself from the proximal portion of the catheter.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was excellent.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7550559
• Report Number: 2134265-2018-04700
• Device Sequence Number: 274789
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2018
• Device Model Number: H7493926012250
• Device Catalogue Number: 39260-1225
• Device Lot Number: 0021567534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1